PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5...
FDA Recall #D-0416-2024 — Class II — November 9, 2023
Product Description
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
SCA Pharmaceuticals, LLC — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,118 syringes in kits
Distribution
Nationwide in the USA
Code Information
Lot #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated